Preoperative Image-guided Identification of Response to Neoadjuvant Chemoradiotherapy in Esophageal cancer

Completed

Conditions: Esophageal cancer
10017990
10017991

Registration Number: NL-OMON50293

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

• Histologically confirmed squamous cell carcinoma or adenocarcinoma of the
esophagus or gastroesophageal junction (i.e. tumors involving both cardia and
esophagus on endoscopy)
• Potentially resectable locally advanced esophageal tumor (cT1b-4a N0-3 M0):
based on standard primary staging by EUS and 18F-FDG PET-CT
• Scheduled to receive neoadjuvant chemoradiotherapy according to the
CROSS-regimen: weekly administration of carboplatin and paclitaxel for 5 weeks
and concurrent radiotherapy (41.4Gy in 23 fractions, 5 days per week) followed
by esophagectomy
• Age > 18 years
• Signed informed consent

Exclusion Criteria

• Patients who meet exclusion criteria for MRI
• Patients who meet exclusion criteria for intravenous gadolinium-based
contrast:
o Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2
o Nephrogenic Systemic Fibrosis (strict contra-indication for gadolinium-based
contrast)
o Known allergy for gadolinium-based contrast
• Patients with a blood plasma glucose concentration >10 mmol/L or poorly
controlled diabetes mellitus
• Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal
dissection (ESD) of primary tumor prior to start of neoadjuvant
chemoradiotherapy
• Pregnant or breast-feeding patients

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A multiparametric prediction model that predicts the probability of a<br /><br>pathologic complete response to nCRT in esophageal cancer by integrating DW-MRI<br /><br>and DCE-MRI in conjunction with 18F-FDG PET-CT scans acquired prior to, during<br /><br>and after administration of nCRT, as compared to the pathological specimen as<br /><br>gold standard.</p><br>

Secondary Outcome Measures